1. DUNS number issues: Maintanence of DUNS numbers is still a major concern for most peopple. For example, if a manufacturer registers its establishment with one DUNS number and a distributor drug lists using a different number for that same manufacturer, there can be some confusion. We will need to know how the numbers will stay consistent across different organizations.
2. Drug Listing Scenarios: Case Scenarios were supposed to be in place to be a reference for companies looking to drug list. However, many have had trouble just getting started. A possible solution can be basic process flows for some common scenarios that we can ask for FDA feedback.
3. FDA Drug Establishment Webinar Followup: Several individuals from the ER/DL subteam attended the Establishment registration webinar held by FDA on October 15th. While the meeting was very helpful and informative, a follow up meeting will be needed to go over drug listing in SPL. It would also be helpful to have a representative from the FDA's Drug Listing Office to answer some questions on the requirements. Many individuals believe that there are misinterpretations of the regulations currently and since there is no change in the regulation, these issues will carry over into the new process. It would be a proactive approach to get a clear understanding now to avoid issues in the future.
4. Next meeting will be on Nov. 5, 2008 at 1 pm EDST.
Maintanence of DUNS numbers is still a major concern for most peopple. For example, if a manufacturer registers its establishment with one DUNS number and a distributor drug lists using a different number for that same manufacturer, there can be some confusion. We will need to know how the numbers will stay consistent across different organizations.
2. Drug Listing Scenarios:
Case Scenarios were supposed to be in place to be a reference for companies looking to drug list. However, many have had trouble just getting started. A possible solution can be basic process flows for some common scenarios that we can ask for FDA feedback.
3. FDA Drug Establishment Webinar Followup:
Several individuals from the ER/DL subteam attended the Establishment registration webinar held by FDA on October 15th. While the meeting was very helpful and informative, a follow up meeting will be needed to go over drug listing in SPL. It would also be helpful to have a representative from the FDA's Drug Listing Office to answer some questions on the requirements. Many individuals believe that there are misinterpretations of the regulations currently and since there is no change in the regulation, these issues will carry over into the new process. It would be a proactive approach to get a clear understanding now to avoid issues in the future.
4. Next meeting will be on Nov. 5, 2008 at 1 pm EDST.